# Wampole Laboratories

- Location (FDA's records): Cranbury, NJ
- FDA decisions: 12 (1976–1997): 12 510(k) clearances
- Product codes: JHI (2), LSR (2), DMR (1), DHN (1), DHA (1), JHJ (1), DCF (1), LFX (1), KTN (1), LQO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Chembio Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/chembio-diagnostic-systems)

## Its most-cited devices
- K965131: Borrelia Burgdorferi Igg/Igm Elisa Test System (1997), cited by 1

## Recent decisions
- K965129: Borrelia Burgdorferi Igm Elisa Test System (Mar 26, 1997)
- K965131: Borrelia Burgdorferi Igg/Igm Elisa Test System (Mar 26, 1997)
- K911444: Rubella Virus Immunological Test System (Aug 30, 1991)
- K882896: One-Step HCG (Oct 31, 1988)
- K883004: Mono-Plus (TM) (Aug 4, 1988)
- K875101: Virogen CMV Antibody Test (Mar 1, 1988)
- K875161: Mat (TM) Microalbumin Test (Feb 17, 1988)
- K791309: Ucg-Lyphotest (Jul 30, 1979)

Source page: https://510kreport.com/company/wampole-laboratories